Vascular hole closure delivery device

ABSTRACT

A surgical delivery instrument for delivering a vascular hole closure device having a hole covering member. The delivery instrument comprises a housing, a plunger and an advancer movable within the housing, the advancer having a first portion and a distal portion hingedly connected to the first portion and forming a casing for supporting the hole covering member. Distal movement of the advancer pivots the casing from an angled position to a more linear position to change the orientation of the covering member from a transverse position to a more aligned position. The plunger is advanceable to advance the covering member into the vessel.

This application claims priority from provisional application Ser. No.61/509,829, filed Jul. 20, 2011 and is a continuation in part ofapplication Ser. No. 13/274,402, filed Oct. 17, 2011 which claimspriority from provisional application 61/409,599, filed Nov. 3, 2010 andis a continuation in part of application Ser. No. 12/854,988, filed Aug.12, 2010, which claims priority from provisional application No.61/241,555, filed Sep. 11, 2009 and is a continuation in part ofapplication Ser. No. 12/358,411, filed Jan. 23, 2009 which claimspriority from provisional application Ser. No. 61/066,072, filed Feb.15, 2008. The entire contents of each of these applications areincorporated herein by reference.

BACKGROUND

1. Technical Field

This application relates to a delivery device for a vascular device andmore particularly to a delivery device for a vascular hole closuredevice.

2. Background of Related Art

During certain types of vascular surgery, catheters are inserted throughan incision in the skin and underlying tissue to access the femoralartery in the patient's leg. The catheter is then inserted through theaccess opening made in the wall of the femoral artery and guided throughthe artery to the desired site to perform surgical procedures such asangioplasty or plaque removal. After the surgical procedure is completedand the catheter is removed from the patient, the access hole must beclosed. This is difficult not only because of the high blood flow fromthe artery, but also because there are many layers of tissue that mustbe penetrated to reach the femoral artery.

Several approaches to date have been used to close femoral access holes.In one approach, manual compression by hand over the puncture site isaugmented by a sandbag or weight until the blood coagulates. With thisapproach, it can take up to six hours for the vessel hole to close andfor the patient to be able to ambulate. This inefficiency increases thesurgical procedure time as well as the overall cost of the proceduresince the hospital staff must physically maintain pressure and thepatient's discharge is delayed because of the inability to ambulate.

In another approach to close the vessel puncture site, a clamp isattached to the operating table and the patient's leg. The clamp appliespressure to the vessel opening. The patient, however, must still bemonitored to ensure the blood is coagulating, requiring additional timeof the hospital staff and increasing the cost of the procedure.

To avoid the foregoing disadvantages of manual pressure approaches,suturing devices have been developed. One such suturing device, sold byAbbott, advances needles adjacent the vessel wall opening and pullssuture material outwardly through the wall adjacent the opening. Thesurgeon then ties a knot in the suture, closing the opening. Onedifficulty with the procedure involves the number of steps required bythe surgeon to deploy the needles, capture the suture, withdraw thesuture, and tie the knot and secure the suture. Moreover, the surgeoncannot easily visualize the suture because of the depth of the femoralartery (relative to the skin) and essentially ties the suture knotblindly or blindly slips a pre-tied knot into position. Additionally,the ability to tie the knot varies among surgeons; therefore success andaccuracy of the hole closure can be dependent on the skill of thesurgeon. Yet another disadvantage of this suturing instrument is thatthe vessel opening is widened for insertion of the instrument, thuscreating a bigger opening to close in the case of failure to deliver theclosure system. It is also difficult to pass the needle throughcalcified vessels.

U.S. Pat. No. 4,744,364 discloses another approach for sealing a vesselpuncture in the form of a device having an expandable closure memberwith a filament for pulling it against the vessel wall. The closuremember is held in place by a strip of tape placed on the skin to holdthe filament in place. However, the closure device is still subject tomovement which can cause leakage through the puncture. Additionally, ifthe suture becomes loose, the closure member is not retained and canflow downstream in the vessel. Moreover, since the suture extendsthrough the skin, a potential pathway for infection is created. Theclosure device in U.S. Pat. No. 5,545,178 includes a resorbable collagenfoam plug located within the puncture tract. However, since coagulationtypically takes up to twenty minutes and blood can leak in between theplug and tissue tract, manual pressure must be applied to the puncturefor a period of time, until the collagen plug expands within the tract.

It would therefore be advantageous to provide a device which would morequickly and effectively close openings (punctures) in vessel walls. Suchdevice would advantageously avoid the aforementioned time and expense ofapplying manual pressure to the opening, simplify the steps required toclose the opening, avoid widening of the opening, and more effectivelyretain the closure device in the vessel.

Commonly assigned U.S. Pat. No. 7,662,161 discloses effective vascularhole closure devices which have the foregoing advantages. It would befurther advantageous to provide a vascular hole closure device which isadjustable to accommodate different tissue thicknesses and applies amore constant clamping/retaining force between the intravascular andextravascular components of the device irrespective of tissue thickness.Such adjustability is achieved in copending commonly assignedapplication Ser. No. 12/854,988, filed Aug. 12, 2010, (hereinafter the'988 application), the entire contents of which are incorporated hereinby reference.

The need exists for an effective delivery instrument to deliver theclosure device of the '988 application to the target site to close thevascular access hole.

SUMMARY

The present disclosure in one aspect provides a surgical deliveryinstrument for delivering a vascular hole closure device having a holecovering member. The delivery instrument comprises a housing, a plungerand an advancer movable within the housing. The advancer has a firstportion and a distal portion hingedly connected to the first portion andforming a casing for supporting the hole covering member, wherein distalmovement of the advancer pivots the casing from an angled position to amore linear position to change the orientation of the covering memberfrom an angled position to a more aligned position. The plunger isadvanceable to advance the hole covering member into the vessel.

In some embodiments, the hole closure device includes first and secondflexible members, the first flexible member having a first engagementmember and the second flexible member having a second engagement member,wherein the plunger has first and second longitudinally extendingopenings and first and second engaging portions. In these embodiments,the first engaging portion limits movement of the first engagementmember and the second engaging portion limits movement of the secondengagement member, wherein the first engagement member is held by thefirst engaging portion until a predetermined force is applied to thefirst engagement member during placement of the closure device at atarget site and the second engagement member is held by the secondengaging portion until a predetermined force is applied to the secondengagement member during placement of the closure device at the targetsite. In some embodiments, the first engaging portion comprises a firstopening in a first grommet aligned with the first longitudinallyextending opening in the plunger and the second engaging portioncomprises a second opening in a second grommet aligned with the secondlongitudinally extending opening in the plunger.

The housing can include an angled inner surface engagable by the casingto pivot the casing to the more linear position.

In some embodiments, the plunger includes a tube and a handle portionpositioned proximally of the tube, and movement of the handle portiondistally advances the tube within a lumen of the advancer. Theinstrument can include a distal stop to limit distal movement of theadvancer.

In some embodiments, the instrument includes a first actuator for movingthe advancer distally which is movable independently of the plunger. Inother embodiments, initial advancement of the plunger moves the advancerdistally and subsequent advancement of the plunger advances the coveringmember into the vessel.

In accordance with another aspect of the present disclosure, a surgicaldelivery instrument is provided for delivering a vascular hole closuredevice having a hole covering member. The delivery instrument comprisesa housing, an advancer movable within the housing, and a plunger. Theadvancer is movable to change the position of the covering member withinthe housing and the plunger is subsequently movable to advance thecovering member from the housing into the vessel.

In some embodiments, movement of the plunger moves the advancer tochange the position of the covering member. In other embodiments, afirst actuator is provided for moving the advancer which is movableindependently of the plunger.

The instrument can include a stop to limit movement of the advancer,wherein the plunger can be movable within the advancer when the advancercomes into contact with the stop.

In some embodiments, first and second rails operatively connect theadvancer and the plunger. The first and second rails can be operativelydissociated from the plunger when the advancer is movable to a distalposition into contact with the stop.

In accordance with another aspect of the present disclosure, a surgicaldelivery instrument is provided for delivering a vascular hole closuredevice having a first flexible member having a first engagement memberextending therefrom and a second flexible member having a secondengagement member extending therefrom. The delivery instrument comprisesa housing having first and second longitudinally extending lumens andfirst and second members, the first member having a first openingaligned with the first lumen and the second member having a secondopening aligned with the second lumen. The first engagement memberpasses through the first opening when a predetermined proximal force isapplied and the second engagement member passes through the secondopening when a predetermined proximal force is applied, wherein thefirst engagement member is held by the first member until thepredetermined proximal force is applied to the first engagement memberduring placement of the closure device at a target site.

Preferably, the second engagement member is held by the second memberuntil the predetermined proximal force is applied to the secondengagement member during placement of the closure device at the targetsite.

In some embodiments, the first and second flexible members of theclosure device are sutures, and the delivery instrument further includesa cutting member positioned within the housing for automaticallysevering the sutures.

In some embodiments, the first member has a third opening and the secondmember has a fourth opening, wherein the first engagement member ispassable through the first opening when a first force is applied andsubsequently passable through the third opening when a subsequent thirdforce is applied. The second engagement member can be passable throughthe second opening when a second force is applied and subsequentlypassable through the fourth opening when a subsequent fourth force isapplied. These forces in some embodiments may vary. The first and thirdforces can be substantially equal or substantially different. The secondand fourth forces can be substantially equal or substantially different.

In some embodiments, the vascular hole closure device has a coveringmember at a distal end for positioning internal of a vessel and a firstand second retainer for positioning external of the vessel, wherein thefirst flexible member extends between the covering member and the firstretainer and the first engagement member is positioned at a proximalportion of the first flexible member, and the second flexible memberextends between the covering member and the second retainer and thesecond engagement member can be positioned at a proximal portion of thesecond flexible member, wherein proximal movement of the deliveryinstrument advances the first retainer and the second retainer towardthe covering member.

A method for delivering a vascular hole device using the aforedescribedinstruments are also provided.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiment(s) of the present disclosure are described hereinwith reference to the drawings wherein:

FIG. 1 is a perspective view of a first embodiment of the hole closuredelivery instrument of the present disclosure;

FIG. 2 is an exploded view of the advancer portion of the deliveryinstrument of FIG. 1;

FIG. 2A is an exploded view of the handle (plunger) portion of thedelivery instrument of FIG. 1;

FIG. 2B is an enlarged view of the area of detail of FIG. 2;

FIG. 3 is a longitudinal cross-sectional view taken along line 3-3 ofFIG. 1 showing the advancer in the initial position;

FIG. 3A is a longitudinal cross-sectional view taken along line 3A-3A ofFIG. 1 showing the handle portion in the initial position;

FIG. 3B is an enlarged view of the area of detail of FIG. 3;

FIG. 4 is a transverse cross-sectional view taken along line 4-4 of FIG.3;

FIG. 5 is a transverse a cross-sectional view taken along line 5-5 ofFIG. 3;

FIG. 6 is a transverse cross-sectional view taken along line 6-6 of FIG.3A;

FIG. 7 is a perspective view of the advancer portion illustratinginitial movement of the sliding tab;

FIG. 8 is a view similar to FIG. 3B showing initial movement of thesliding tab;

FIG. 8A is a longitudinal cross-sectional view similar to FIG. 3 showinginitial movement of the sliding tab to advance the advancer tube andcorresponding to the position of FIG. 7, and further showing the sheathconnected to the instrument;

FIG. 8B illustrates the sliding tab adjacent the lockout;

FIG. 8C illustrates the sliding tab advanced past the lockout;

FIG. 9 is a perspective view similar to FIG. 7 showing the sliding tabin the distal position to fully advance the advancer tube;

FIG. 10 is a longitudinal cross-sectional view similar to FIG. 8Ashowing the sliding tab in the distal position to fully advance theadvancer tube and corresponding to the position of FIG. 9;

FIG. 11 is a perspective view similar to FIG. 9 illustrating the slidingtab in the distal position and the handle portion advanced to the distalposition to deploy the hole closure device in the vessel;

FIG. 12 is an enlarged view of the area of detail of FIG. 11;

FIG. 13 is a longitudinal cross-sectional view similar to FIG. 10showing the sliding tab in the distal position and the handle portionadvanced to the distal position, corresponding to the position of FIG.11;

FIG. 14 is a perspective view illustrating initial retraction of thedelivery instrument to further deploy the hole closure;

FIG. 15 is an exploded view of a portion of the handle portion (plunger)showing a first housing half section with initial movement of the secondengagement member and the first engagement member engaged with the loweropening of the distal blocking element in the central housing;

FIG. 16 is a longitudinal cross-sectional view of the handle portion ofthe delivery instrument corresponding to the position of FIG. 15illustrating proximal movement of the handle portion of the deliveryinstrument to advance the first retainer of the closure device towardthe covering member;

FIG. 17 is an exploded view of a portion of the handle portion showingthe first housing half section with further movement of the firstengagement member in the lower channel of the central housing and thesecond engagement member engaged with the proximal blocking element inthe lower channel of the first housing;

FIG. 18 is a longitudinal cross-sectional view of the handle portion ofthe delivery instrument corresponding to the position of FIG. 17illustrating further proximal movement of the handle portion of thedelivery instrument to advance the second retainer of the closure devicetoward the covering member;

FIG. 19 is a view similar to FIG. 15 illustrating the first engagementmember in the curved channel of the central housing and the secondengagement member engaged with the proximal blocking member at the upperopening;

FIG. 20 is a cross-sectional view of the proximal end of the handleportion of the delivery instrument corresponding to the position of FIG.19 and showing further advancement of the second retainer of the closuredevice toward the covering member;

FIG. 21 is a view similar to FIG. 19 illustrating the first engagementmember engaging an upper opening in the distal blocking member and thesecond engagement member in the upper channel of the central housing;

FIG. 22 is a cross-sectional view of the proximal end of the handleportion of the delivery instrument corresponding to the position of FIG.21 and showing further proximal movement of the handle portion of thedelivery instrument to further advance the first retainer of the closuredevice toward the covering member;

FIG. 23 is a perspective view of a region of the handle portion showingthe sutures adjacent the cutting blade;

FIG. 24 is a cross-sectional view corresponding to the position of thesecond suture in FIG. 23;

FIG. 25 is a perspective view similar to FIG. 23 showing the suturesengaged with the cutting blade;

FIG. 26 is a cross-sectional view similar to FIG. 24 corresponding tothe position of the second suture in FIG. 25;

FIG. 27 is a perspective view of a hole closure delivery instrument inaccordance with an alternate embodiment of the present disclosure;

FIG. 28 is a cross-sectional view taken along line 28-28 of FIG. 27;

FIG. 29 is a front view of the delivery instrument of FIG. 27;

FIG. 30A is an exploded view of the advancer portion of the deliveryinstrument of FIG. 27;

FIG. 30B is an exploded view of the handle portion (plunger) of thedelivery instrument of FIG. 27;

FIGS. 31A, 31B and 31C are longitudinal cross-sectional views takenalong lines 31A-31A, 31B-31B and 31C-31C of FIG. 27 showing the deliveryinstrument (handle portion and advancer) in the initial position;

FIG. 32 is a perspective view of a section of the delivery instrument ofFIG. 27 showing removal of the locking tab;

FIG. 33 is a partially exploded view of the advancer portion with theadvancer in the initial position (only one of the housing halves isshown);

FIGS. 34A, 34B and 34C are longitudinal cross-sectional views similar toFIG. 31A, 31B, 31C showing initial distal movement of the handle portion(plunger) to move the advancer to the distal position to align thecasing for the hole closure device and advance it into the sheath;

FIG. 35 is a partially exploded view similar to FIG. 33 corresponding tothe position of the handle portion and advancer of FIGS. 34A-34C;

FIGS. 36A and 36B are longitudinal cross-sectional views similar toFIGS. 34A and 34B showing further distal movement of the handle portionto move the rails into the spaces in the housing;

FIG. 37 is a partially exploded view similar to FIG. 35 corresponding tothe position of the handle portion and the advancer of FIGS. 36A and36B;

FIG. 38 is a partially exploded view similar to FIG. 37 showing thehandle portion fully advanced to the distal position;

FIGS. 39A, 39B and 39C are longitudinal cross-sectional views similar toFIGS. 34A, 34B and 34C showing full advancement of the handle portion tothe distal position;

FIG. 40 is a cross-sectional view taken along line 40-40 of FIG. 39A;and

FIG. 41 is a perspective view showing retraction of the deliveryinstrument after full advancement of the handle portion to furtherdeploy the hole closure device.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now in detail to the drawings wherein like reference numeralsidentify similar or like components throughout the several views, thepresent application is directed to a delivery instrument for deliveringa vascular hole (aperture) closure device. The closure device isintended to close an aperture in the vessel wall, typically formed afterremoval of a catheter previously inserted through the vessel wall intothe vessel lumen for performing angioplasty or other interventionalprocedures. The aperture extends through the patient's skin andunderlying tissue, through the external wall of the vessel, through thewall of the vessel, and through the internal wall of the vessel tocommunicate with the internal lumen of the vessel. The closure device ofthe present disclosure has an intravascular component to block bloodflow and an extravascular component to retain the intravascularcomponent.

The hole closure device 101 is illustrated in FIGS. 12, 16, 18, 20 and22 in various stages of delivery and is described in more detail inpatent application Ser. No. 12/854,988, filed Aug. 12, 2010,(hereinafter the '988 application), the entire contents of which areincorporated herein by reference. The closure device includes a coveringmember or patch 104 positioned within the vessel against the internalwall of the vessel to block blood flow through the vessel aperture andtwo retainers 110, 112 positioned external of the vessel wall to retainthe covering member 104 in its blocking position. Each retainer 110, 112is preferably spherical in configuration and is fixedly attached to arespective suture 122, 120, such that pulling of the respective sutureadvances the attached retainer toward the covering member 104 toultimately position the retainers 110, 112 in a side by siderelationship either against or adjacent the external surface of thevessel wall.

Covering member 104, preferably elongated in configuration as shown, isretained in a delivery sheath in a longitudinal position for delivery tothe vessel, and then pivots to a transverse position within the vessellumen (substantially perpendicular to an axis extending through theaperture) for orientation to cover (patch) the vessel aperture on theinternal side. This movement is illustrated in FIGS. 37A-37D of U.S.Pat. No. 7,662,161, the entire contents of which are incorporated hereinby reference (hereinafter the '161 patent).

The elongated covering member 104 functions to cover (patch) theinternal opening in the vessel wall to prevent the egress of blood. Thecovering member 104 is preferably somewhat oval shaped with elongatedsubstantially parallel side walls 106 a, 106 b, and end walls 108, 108 bconnecting the side walls 106 a, 106 b. Other shapes of the coveringmember are also contemplated. The end walls 106 a, 106 b can havesubstantially straight wall portions, or curved wall portions. Coveringmember 104 preferably has a thicker region in the central region thanthe first and second end regions. Other dimensions and configurationsare also contemplated.

The longitudinal axis of covering member 104 defines a lengthwisedimension and transverse axes define a shorter widthwise dimensions. Thewidthwise dimension of the covering member 104 is preferably, for a 6 Frdevice, in the range of about 2.5 mm to about 3.5 mm, and morepreferably about 3.1 mm. Other dimensions are also contemplated. Thewidth preferably is at least substantially equal to the dimension of theinternal opening in the vessel wall to effectively cover the opening. Ina preferred embodiment, the covering member 104 has a length in therange of about 7.5 mm to about 9 mm (in a 6 French system), andpreferably about 8 mm.

It should be appreciated that alternatively the covering member could beprovided with an enlarged width region as illustrated in the embodimentof FIG. 1 of the '161 patent. The covering member could also beconfigured asymmetrically so that the enlarged region is off-centered toaccommodate widening of the aperture as the member is pulled at anangle. The covering member could also be configured in a paddle shapedwith a narrowed region adjacent a wider region as in FIGS. 9B-9E of the'161 patent. Other covering member configurations including thosedisclosed in the '161 patent could be utilized with the retainers ofthis present application.

The elongated covering member can be composed of materials such aspolycarbonate or polyurethane. Preferably it is composed of resorbablematerials such as lactide/glycolide copolymers that after a period oftime resorb in the body. If composed of resorbable material, thecovering member could optionally have regions of varying resorbability.Varying degrees of resorbability can be achieved for example byutilizing different materials having differing resorbablecharacteristics or by varying the mass of the covering member (increasedmass increases resorbtion time).

Spherical retainers 110, 112 are preferably composed of resorbablematerial. In a preferred embodiment, the diameter of each retainer 110,112 is about 0.090 inches to about 0.095 inches, although otherdimensions are contemplated. Although shown as spheres, other shapesincluding other rounded shapes are also contemplated. The retainerscould alternatively be made of non-absorbable polymeric or metallicmaterial.

When the retainers 110, 112 are released from the delivery instrument,they are spaced further from the covering member 104. They are thenconfigured to be advanced toward the covering member 104. Morespecifically, each retainer 110, 112 is fixedly secured to a respectiveflexible connecting member such as suture 122, 120. Sutures 122, 120 arepreferably made of polymeric material and are preferably resorbable,composed of a material such as polydioxanome. It is also contemplatedthat alternatively a metallic material could be utilized. The sutures,retainers and covering member can be made of the same or differentresorbable material, and/or have the same or different resorption times.

Details of the hole closure device as well as various embodiments of thedevice are shown and described in the '988 patent application previouslyincorporated by reference herein.

Suture 120 has a second end 120 a (FIG. 2A) and a first opposite endsecured to retainer 112 by molding, gluing, forming a knot, or othermethods. Similarly, suture 122 has a second end 122 a and a firstopposite end secured to retainer 110 in any of the foregoing manners.Various methods of attachment are shown in the '988 application.

To advance the retainers 110, 112 toward the vessel wall (and coveringmember), the ends 122 a, 120 a of each suture 122, 120 is pulledproximally, thereby moving the respective retainer in the oppositedirection closer to the aperture and vessel wall. This is described indetail below in conjunction with the delivery instrument. Note that oncethe retainers 110, 112 are tightened against the tissue, a sufficientretention force is maintained, i.e. a proximal pulling force on thecovering member 104 to pull it slightly proximally against the vesselwall. The retainers 110, 112 therefore help to prevent the coveringmember 104 from separating from the vessel wall (e.g. moving in thedirection toward the opposing vessel wall) which could create anunwanted gap between the covering member 104 and the vessel opening toallow blood flow. The extent to which the retainers 110, 112 move towardthe wall (and thus their distance from the vessel wall in their finalplacement position) will depend on the tissue thickness. Thus, theclosure device can adjust for different tissue thicknesses and apply aconstant retention force regardless of tissue thickness.

The covering member 104 as shown in FIG. 16 has a first pair of holesand a second pair of holes. The first pair of holes 116, 117 receivesuture 120 and the second pair of holes 119, 114 receive suture 122.Holes 114, 117 have a smaller diameter than holes 116, 119. The largerhole 116 is dimensioned to receive suture 120 for free unrestrictedmovement of the suture 120 therethrough and therefore easier applicationof spherical retainer 112. Similarly, the larger hole 119 is dimensionedto receive suture 122 for free unrestricted movement of the suture 122therethrough and therefore for easier application (movement) ofspherical retainer 110. Smaller hole 114 is dimensioned to frictionallyengage suture 122 so that tension is applied to the suture 122. It isdimensioned so that the suture 122 can be pulled through the hole 114 ifsufficient force is applied by pulling on second end 122 a, but if suchpredetermined force is not applied, the suture will remain frictionallyengaged within the wall of the opening 114 and not move. In this manner,when tension on end 122 a is terminated, the suture 122 and thus thespherical retaining ball 110 will remain in position. Suture 120operates in a similar manner, with smaller opening 117 dimensioned tofrictionally engage and resist movement of the suture 120 to retainspherical retaining ball 112. Preferably, each hole 114, 117 has aninwardly angled wall transitioning into a reduced diameter region and anoutwardly angled wall transitioning back to a larger diameter. Theangled walls facilitate movement of the suture when tension is applied,with the reduced diameter region frictionally securing the suture. Hole117 has a similar configuration as hole 114 and thus also containssimilar angled walls. In this manner, when tension on end 120 a isterminated, the suture 120 and thus the spherical retaining ball 112will remain in position.

As shown in FIGS. 16 and 18, retainer 110 is pulled towards the smallerhole 114 and retainer 112 is pulled toward the smaller hole 117.However, it is also contemplated, to facilitate manufacture, that thesutures could be reversed so the retainer 110 is pulled toward thelarger hole 116 and the retainer 112 is pulled toward the larger hole119.

A crimp or a bead can be attached to the suture, or a knot formed in thesuture, creating a diameter larger than the diameter of portion withinthe retainer which forms a shoulder to block movement of the respectivespherical retainer 110 or 112. Consequently, this frictional engagementprevents the respective retainer from sliding in the direction away fromthe covering member 104 while the shoulder prevents the retainer fromsliding in the direction toward the covering member 104. The retainer112 and suture 120 preferably have the same structure andengagement/retention as retainer 110 and suture 122.

Note that during delivery the covering member 104 emerges from thedelivery sheath and moves from a tilted position, more aligned or inpreferred embodiments substantially aligned with the longitudinal axisof the sheath, to a transverse position within the vessel. This is dueto a preset in the sutures which maintains the covering member in thetransverse position.

As can be appreciated, covering member 104 is pulled proximally to abutthe internal opening on the internal side of the vessel to cover (patch)the opening and the sutures extend through the opening in the vesselwall. Note that in the delivery position, the retainers 110 and 112 arepreferably in a stacked relationship within the delivery instrument tominimize the transverse dimension of the delivery system.

Then, to retain the covering member 104 in position against the vesselwall to block blood flow therethrough, sutures 120, 122 are pulledproximally from their ends 120 a, 122 a, thereby advancing the retainers112, 110 toward the vessel wall and covering member 104. The retainers112, 110 can be moved to a position contiguous to the vessel wall, ordepending on tissue thickness, may be adjacent the wall with some tissueinterposed between the retainers and vessel wall. The retainers 110, 112in this position apply a proximal force on the elongated covering member104 to limit movement of the covering member into the vessel. Theretainers in this placement position are preferably in a substantiallyside by side relationship. The instrument for delivering these elementsto the target site to close the vessel opening is described in detailbelow.

As shown in FIG. 22, in the side by side relationship, the retainers110, 112 are alongside in a transverse orientation with respect tocovering member 104. That is, they are positioned along the width of thecovering member 104 However it is also contemplated that the retainersin the placement position can be in a lengthwise orientation(substantially parallel to the longitudinal axis of the coveringmember.) The retainers could also be in other side by side arrangementsat angles to the longitudinal axis. Alternatively, the retainers can bepartially stacked in the placement position.

Turning now to the delivery instrument of the present disclosure andwith initial reference to FIGS. 1 and 2, the delivery instrument isdesignated generally by reference numeral 10 and includes a handleportion or handle housing 12, an elongated outer tube 14 extendingdistally from the handle portion 12, and an advancer portion 16. Handleportion 12, as shown in FIG. 2A, includes a first housing half 40, asecond housing half 42 and a central housing support 44 which togetherform channels for passage of the sutures. Further details of the handleportion (plunger) 12 are described in detail below.

The delivery instrument 10 for inserting the closure device extendsthrough an opening in the patient's skin, through the underlying tissue,through an external opening in the vessel wall, through the aperture inthe vessel wall, and through an internal opening on the internal side ofthe vessel wall into the vessel lumen.

The delivery instrument 10 deploys the hole closure device 101 in amultiple step process. In the first step, the advancer portion 16reorients the hole closure device 101 and advances the hole closuredevice from the delivery instrument 10, and into a proximal end of asheath (FIG. 10). In the second step, the handle portion 12 is advancedwith respect to the advancer portion 16 to advance the hole closuredevice 101 through the sheath 200 and into the vessel lumen of apatient. In the third step, the entire delivery instrument 10 isretracted proximally to move the retainers 110, 112 toward the coveringmember 104. This multiple step process is described in detail below.

Turning first to the advancer portion 16 of the delivery instrument, andwith initial reference to FIGS. 2 and 3, advancer portion 16 includes awinged housing 22, a guide housing 30 and an advancer tube 39. Advancertube 39 is slidably positioned within a lumen in guide housing 30.Winged housing 22 has radially extending wings 22 a, 22 b to be grippedby the user during use, e.g. to aid in retraction of the deliveryinstrument 10 after the hole closure device 101 is deployed in thevessel. Distal end 23 a of winged housing 22 is dimensioned to receivecap 20 thereover, preferably connected by an interference fit, andproximal end 23 b is dimensioned to be received within opening 35 ofconnector portion 34 of guide housing 30, also preferably providing aninterference fit. Winged housing 22 can also be connected to connectorportion 34 of housing 30 by groove/projection snap fit, a threadedengagement or any other method of attachment. Similarly, cap 20 andwinged housing 22 can also be connected by groove/projection snap fit, athreaded engagement or any other method of attachment. Cap 20 has a pairof tabs 21, preferably formed by cutouts 20 in the housing, to engage asheath 200 as shown in FIG. 8A to connect the sheath to the wingedhousing 22. Opening 20 a in cap 20 allows for a side tube of the sheath200, the side tube enabling fluid injection through the sheath 200.

Seal 28 is supported within an opening 35 of connector portion 34 ofhousing 30 to prevent ingress of fluids. Seal 28 has an opening 29dimensioned and configured to receive advancer tube 39 therethrough.

Advancer tube 39 forms a cheater tube slidable within winged housing 22and guide housing 30. Advancer tube 39 is in the form of a tube cut atthe distal end to form a hinge 39 b (FIG. 2). The cut portion forms acasing 26. Casing 26 is somewhat cylindrical shaped with a beveled end26 a formed by the cut in the tube. Casing 26 forms a support housingfor the covering member 104 of hole closure device 101. The casing 26 isinitially mounted within the lumen of winged housing 22 in a positionsubstantially transverse to a longitudinal axis of the winged housing 22as shown in FIG. 3. Distal movement of the advancer tube 39 pivots thecasing 26 (FIG. 8A) about hinge 39 b at it contacts curved wall 22 cwithin winged housing 22 to a more linear position substantially alignedwith the longitudinal axis of the winged housing 22 as shown in FIG. 10.This allows for pivoting movement of the elongated covering member 104from a transverse position to reposition it to a more aligned positionfor advancement through the sheath 200. The deployment of the closuredevice 101 is described in more detail below. Casing 28 is pivoted andmoved within the tubular channel 24 of winged housing 22, exitingopening 249. Note also that in the substantially aligned position ofcasing 26 of FIG. 10, the beveled distal end 39 a of advancer tube 39abuts the beveled end 26 a of casing 26.

Guide housing 30 of advancer portion 16 has a pair of slots 30 a formedin the outer wall and on opposing sides thereof. Slots 30 a extendlongitudinally along the housing 30 and are each configured anddimensioned to receive a sliding finger tab 37. More specifically andwith reference to FIGS. 2 and 2B, each sliding tab 37 has a post 37 aextending radially inwardly toward the longitudinal axis of the housing30. Each post 37 a extends through an opening 36 a (preferably hexagonalalthough are shapes are contemplated) in proximal end cap 36 of advancertube 39. In this manner, movement of the sliding tabs 37 within slots 30a causes sliding movement of the advancer tube 39 through guide housing30. This is shown in FIGS. 7-10, wherein in FIGS. 7 and 8A, sliding tabs37 have been moved slightly distally from their initial position of FIG.1 causing slight distal movement of the advancer tube 39 from itsinitial position. As can be appreciated, in this position, casing 26 hasbegun to be pivoted about hinge 39 b at the distal end of advancer tube39. In FIGS. 9 and 10, sliding tabs 37 have been moved further distallyto their distal position, causing further distal movement of advancertube 39 to its distal position. This causes full rotation of casing 26to its aligned position and movement of casing 26 into a proximal regionof sheath 200.

Cap 36 of advancer tube 39 has a pair of openings 36 b on opposing sidesto receive tabs 82 of cap housing 80 (FIG. 2A) of handle portion 12discussed below.

In the initial proximal position of sliding tabs 37, a stop 31 limitstheir distal movement. Stop 31 in is the form of a finger formed by acutout in housing 30, and can be provided for each tab 37, oralternatively a single stop can be provided to engage one of the slidingtabs 37. The finger 31 projects into slot 30 a providing a bump 31 a toblock movement of tab 37 as flat 37 b (FIG. 2B) on the distal side ofblock 37 d supporting post 37 abuts finger 31. That is, as flat 37 bcontacts finger (stop) 31, finger 31 prevents inadvertent movement ofthe sliding tabs 37, such as during shipping. In order to distallyadvance the tabs 37, sufficient force must be applied to override thestop 31, e.g. flex the finger 31 out of the path of the block 37 d soblock 37 d of tab 37 can continue along slot 30 a.

Lockout 32 is positioned distal of stop 31 and locks sliding tabs 37 intheir distal position. A lockout 32 can be provided on each side of thehousing 30 (at the distal end of each slot 30 a) or alternatively onlyone lockout can be provided to lock one of the sliding tabs 37 whichwould effectively lock both tabs 37. More specifically, the lockout isin the form of two fingers 32 formed by cutouts in housing 30 whichproject into slot 30 a, thereby narrowing the slot 30 a at region 30 b(FIG. 3). Upon distal movement of tabs 37, flat 37 b forces fingers 32out of the path to move past the fingers 32 as shown in FIGS. 8B and 8C.Flat 37 c on the opposing side of flat 37 b then engages edge 32 a offingers 32 to prevent retraction of tab 37, thereby locking tabs 37 andthus advancer tube 39 in the forward (distal) position.

Referring back to FIG. 2, an inner tube 15 is concentrically mountedwithin lumen 14 c of outer tube 14. Outer tube 14 has a proximal end 14a extending from the handle housing 12 and connected within opening 84to cap 80 (FIG. 2A) of housing 12. A distal end 14 b of inner tube 14extends into the guide housing 30 and is configured to abut the retainerof the hole closure device 101 to advance it through the sheath 200.Inner tube 15 has a proximal end 15 a and a distal end 15 b, withproximal end 15 a connected to connector 88 (FIG. 2A). Inner tube 15 hasfirst and second channels 17 a, 17 b to receive sutures 120, 122.

Turning now to the handle portion 12 which provides the second step inadvancement of the hole closure device 101, and with initial referenceto FIGS. 2A and 3A, handle portion 12 includes a housing or outer casing13 containing a central housing 44 and first and second channel housinghalves 40, 42, respectively, which are mirror images of each other.Central housing 44 is mounted between housing halves 40 and 42. Each ofthe housing halves 40, 42, 44 taper to a reduced diameter portion at thedistal end.

Channel housing half 40 has a plurality of axially spaced openings 45 toreceive radially extending tabs 56 of central housing 44. Similarly,channel housing half 42 has a plurality of axially spaced openings 51 toreceive radially extending tabs 55 of central housing 44. Thistab/opening engagement connects the housings 40, 42 and 44 together.

First channel housing 40 together with a first side of central housing44 (e.g. the left side as viewed in FIG. 2A) together from a channel forpassage of the suture 120 and engagement member 125 secured to thesuture 120 in order to advance the retainer 112 toward the coveringmember 104 of hole closure device 101. Second channel housing 42together with a second side of central housing 44 (e.g. the right sideas viewed in FIG. 2A) together from a channel for passage of the suture122 and engagement member 123 secured to the suture 122 in order toadvance the retainer 110 toward the covering member 104 of hole closuredevice 101.

With continued reference to FIG. 2A, housing 40 has a lower channel 40a, an upper channel 40 b, and a curved channel 40 e joining channels 40a, 40 b at their proximal end. At the distal end of upper channel 40 b,the upper channel 40 b transitions into an angled channel 40 c and theninto a longitudinally extending channel 40 d extending substantiallyparallel to the longitudinal axis of the housing 40. The angled channel40 c facilitates severing of the suture 120 discussed in more detailbelow. Identical channel portions are on housing half 42. Thus, housinghalf 42 has an upper channel, a lower channel, a curved channel joiningthe upper and lower channels at a proximal end, an angled channel and alongitudinally extending channel.

The central support 44 has a channel on each of its sides to cooperatewith the channel in the housing halves 40, 42, thereby together formingthe channel (passage) for the respective suture 120, 122 and engagementmember 125, 123. This can be best understood in FIG. 2A wherein centralhousing 44 has a lower channel 58 a, an upper channel 58 b and a curvedchannel 58 c at the proximal end joining lower channel 58 a and upperchannel 58 b. Central support 44 has the identical channel configurationon the opposing side, except as noted below. Thus, on the opposing side,the upper, lower and curved channels of central housing 44 cooperatewith the channels 40 a, 40 b and 40 e of first housing 42. On the sideshown in FIG. 2A, the channels 58 a, 58 b and 58 c of housing 44cooperate with the upper, lower and curved channels of housing 42.

The only difference in the channels on opposing sides of central housing44 is the recess to receive the respective grommet 48, 49. Morespecifically, central housing 44 has a distal recess or groove 57cooperating with a recess on housing 42 for mounting of distal grommet49. A proximal recess or groove is formed on the opposing side ofcentral housing 44, cooperating with the proximal recess 47 of housing40 to provide a recess or groove to receive proximal grommet 48.

Distal grommet 49 is illustratively semi-circular in cross-section andhas a flat surface for positioning within recess 57 of central housing44. Other geometries are also contemplated to key the grommets such asthe asymmetric configuration shown in FIG. 30B for example. Grommet 49forms an abutment member or blocking member for engagement member 123attached to the end of suture 122. Grommet 49 has a lower opening 49 aaligned with lower channel 58 a (and corresponding lower channel onhousing half 42) and an upper opening 49 b aligned with upper channel 58b (and corresponding upper channel on housing half 42). Preferably,upper opening 49 b is smaller than lower opening 49 a to provide anincreased frictional force for passage of engagement member 123therethrough.

Proximal grommet 48 is illustratively semi-circular in cross-section andhas a flat surface 48 d for positioning within a recess of centralhousing 44. As with grommet 49, other geometries are also contemplated,such as that shown in FIG. 30B. Grommet 48 forms an abutment or blockingmember for engagement member 125 attached to the end of suture 120.Grommet 48 has a lower opening 48 a aligned with lower channel 40 a (andcorresponding lower channel on central housing 44) and an upper opening48 b aligned with upper channel 40 b (and corresponding upper channel oncentral housing 44). Preferably upper opening 48 b is smaller than loweropening 48 a to provide an increased frictional force for passage ofengagement member 125 therethrough.

An elongated knife slot 41 is formed in housing 40 and an identicalknife slot is formed in housing 42. These knife slots extendsubstantially parallel to a longitudinal axis of the housings 40, 42.The knife slots are aligned with knife slot 52 in central housing 44 toreceive knife 54. Knife 54 has a substantially planar surface 54 a and aproximally directed sharp edge 54 b to sever sutures 120, 122 asdescribed in detail below.

At the distal end of casing 13 is a cap 80 having a central opening 84to receive outer tube 14 and concentric inner tube 15. A pair of fingertabs 82 extending distally from a distal surface 80 a snap into openings36 b of cap 36 of advancer tube 39 (FIG. 2) when the handle housing 12is advanced to its distalmost position (see e.g. FIG. 13). Connector 88has an opening 87 a in tubular portion 87 to receive outer tube 14 andconcentric inner tube 15. A spring 70 can also be provided to act as aspacer.

After the advancer tube 39 is advanced by tabs 37 in the mannerdescribed above, the handle housing 12 is advanced distally, preferablyin increments, causing outer tube 15 to contact the proximallypositioned retainer 112 of hole closure device 101 and advance itthrough the sheath 200 and out the distal end thereof. This is shown inFIG. 11, wherein the sheath has been removed for clarity. The handlehousing 12 is advanced until tabs 82 of cap 80 lockingly engage advancertube cap 36 as the tabs 82 extend through openings 36 b and snap fittherein as shown in FIG. 13. After such full advancement of housing 12,the covering member 104 and retainers 110, 112 are positioned in thevessel, with the retainer 104 moving to a transverse position due to thepre-set of the sutures 120, 122. That is, the sutures 120, 122 arepreset at an angle of about 90 degrees such that when the coveringmember 104 is free of the confines of the sheath 200, it automaticallypivots to the transverse position of FIGS. 11 and 12.

Once the handle portion 12 is advanced and locked to the advancerportion 16, the delivery instrument 10 is then retracted in thedirection of the arrow of FIG. 14. Retraction of the handle housing 12moves the sutures 120, 122 and engagement members 125, 123 through thechannels in the housings 40, 42, 44 as described in detail below. Thus,as can be appreciated, in use, in this multiple step process, first theadvancer tube 39 is advanced to rotate the casing 26 to the positionshown in FIG. 10 and to move it into the proximal region of the sheath200. Next, the handle portion 12 is advanced relative to the fixed(locked) advancer portion 16 to advance the hole closure device 101through the sheath 200 and out the distal end thereof. Once the handleportion 12 has completed its distal travel and interlocked with advancerportion 16, the handle portion 12 (and the entire delivery instrument10) is retracted thereby securing the patch 104 by movement of theretainers 110, 112 in sequence towards the covering member 104.

The engagement members 123, 125 move within the channels and interactwith the grommets 48, 49. The grommets 48, 49 have openings providingengaging portions or abutment or blocking members which provideresistance to movement of the sutures 120, 122. This resistance isachieved by the provision of engagement members 123, 125 on the ends ofsuture 120 and suture 122. More specifically, an engagement member 125,illustratively substantially spherical in configuration, although othershapes are contemplated, is positioned at the end 120 a of suture 120.Similarly, an engagement member 123, illustratively substantiallyspherical, although other shapes are contemplated, is positioned at theend 122 a of suture 122. Engagement members 125, 123 can be attached bymethods such as crimping, tying a knot, overmolding, etc. and areconfigured to engage respective grommets 48, 49 to provide resistance tosuture movement.

The use of the delivery device 10 to deliver hole closure device 101will now be described. Note delivery instrument is connected to adelivery sheath 200. The delivery sheath 200 is inserted through theskin, the tissue puncture tract extending to the vessel wall, andthrough the vessel wall into the vessel lumen. In the initial position,the retainers 110 and 112 are positioned within advancer tube 39 withinwinged housing 22 as shown in FIG. 3. Covering member 104 is maintainedin a transverse position within casing 26. In this initial position,engagement members 125 and 123 of sutures 120, 122, respectively, areout of engagement with the respective grommets 48, 49 of the handlehousing 12.

To deploy the closure device 100, the advancer tube 39 is advanceddistally by finger tabs 37 to pivot casing 36 from the initial positionof FIG. 3, through the position of FIG. 8A, to the position of FIG. 10(due to curved wall 22 c), thereby aligning the covering member 104longitudinally for passage through the winged housing 22 and sheath 200,and moving the casing 36 into the proximal region of the sheath 200.Note the tabs 37 of advancer portion 16 are locked in their distalposition by locking fingers 32 of guide housing 30.

Next, handle housing 12 is moved distally relative to the fixed advancerportion 16 such that outer tube 15 advances through fixed advancer tube39 to contact retainer 112 to advance the hole closure device 101through the sheath 200 and out the distal end of the sheath as shown inFIG. 13 (see also FIGS. 11 and 12). Note that handle housing 12 in itsdistal position interlocks with the advancer portion 16 due to theengagement of tabs 82 of cap 80 with openings 36 b in advancer tube endcap 36. Once the covering member 104 is exposed, it pivots within thevessel lumen from a first delivery position more aligned with thelongitudinal axis of the delivery sheath to a transverse placementposition as shown in FIGS. 11-13.

The delivery instrument 10 is then retracted proximally in the directionof the arrow of FIG. 14 to place the covering member 104 against theinternal side of the opening in the vessel wall to patch or cover thevessel wall opening. FIGS. 11 and 12 show the initial position of theretainers 110, 112 when the closure device 101 is initially insertedinto the vessel lumen.

When the delivery instrument 10 is retracted further such that thecovering member 104 abuts the internal vessel wall, further retractionof the delivery instrument 10 will deploy the retainers 110, 112 asfollows. In the initial position of FIG. 3, engagement member 125 iswithin lower channel 40 a of housing 40 (FIG. 2A) and engagement member123 is in lower channel 58 a of central housing 44 slightly distal oflower opening 49 a of proximal grommet 49 (FIG. 3A). It should beappreciated that as discussed herein, the channels of housing 42cooperate with the channels on one side of central housing 44 and thechannels of housing 40 cooperate with the channels on the opposing sideof central housing 44. Thus, for brevity, only one of the cooperatingchannels is mentioned, it being understood that the channels are formedby cooperation of these components.

Upon further proximal retraction of the handle housing 12, suture 122 ispulled proximally such that engagement member 123 of suture 122 ispulled against an engaging portion of grommet 49, i.e., opening 49 a ingrommet 49, as shown in FIGS. 15 and 16. (Note the force of coveringmember 104 against the vessel wall provides a counter force such thatproximal movement of the delivery instrument 10 and sutures 120, 122cause distal movement of the retainers 110, 112 attached to the sutures122, 120). The pulling (tensioning) of the suture 122 causes retainer110, attached to the opposing end of suture 122, to move toward thecovering member 104 as shown in FIG. 16. Note that the engagement member125 of suture 120 is not yet engaged with proximal grommet 48. In thisposition, distal grommet 49 provides a stop to restrict movement of thesuture 122. This engagement also provides a tactile feel to the user toindicate that retainer 110 has moved a substantial distance towardcovering member 104.

When delivery instrument 10 is pulled further proximally with respect tothe delivery sheath 200 it pulls (tensions) suture 120 proximally tomove retainer 112 toward covering member 104 as shown in FIG. 18. Suchmovement continues until engagement member 125 abuts/engages an engagingportion of proximal grommet 48, i.e., at lower opening 48 a of proximalgrommet 48, as shown in FIGS. 17 and 18. Grommet 48 thereby provides astop to limit movement of the suture 120. Grommet 48 also provides atactile feel to the user to indicate that retainer 112 has moved asubstantial distance toward covering member 104. Note that engagementmember 123 has already overcome distal grommet 49, and passed throughits lower opening 49 a, and is no longer in tension. As can beappreciated, retainers 110 and 112 have now been moved adjacent thecovering member 104 but not yet in their fully distal securementposition. Note this delivery method distributes the force, e.g. reducesthe load on the patch.

Continued proximal movement of delivery instrument 10 applies sufficienttension on suture 120 so engagement member 125 passes through loweropening 48 a of grommet 48 and continues its travel around curvedchannel 40 e until it engages grommet 48 at upper opening 48 b. Thisposition is shown in FIGS. 19 and 20. This moves retainer 112 furtherdistally toward covering member 104 to tighten retainer 112 with respectto covering member 104. Note engagement member 123 continues itsmovement along upper channel 58 b (after passing around proximal curvedchannel 58 c) toward upper opening 49 b of distal grommet 49.

Continued proximal movement as shown in FIGS. 21 and 22 pulls suture 122proximally, moving engagement member 123 into engagement with upperopening 49 b. Engagement member 125 has overcome engagement withproximal grommet 48. Further movement of suture 122 moves retainer 110further distally toward covering member 14, thereby tightening retainer110 with respect to covering member 104, securing the covering member104 in position. Note the extent of movement of the retainers 110, 112toward the covering member 104, i.e. the final distance between theretainers 110 and 112 and covering member 104, will depend on thethickness of the patient's tissue.

With placement of the retainers 110 and 112 within the tissue tractleading to the vessel opening (but outside the vessel opening), thesutures 122, 120 are now severed automatically by the cutting blade 54of delivery instrument 10. This is illustrated in FIGS. 23-26.

As the delivery instrument 10 is pulled further proximally, engagementmembers 125, 123 and sutures 120, 122 enter angled channel 40 c onchannel housing half 40 and an identical angled channel on the opposingchannel housing half 42. As delivery instrument 10 is retracted furtherand sutures 120 and 122 are retracted further, engagement members 123,125 move within longitudinal channel 40 d on housing 40 (FIGS. 23 and24) and an identical longitudinal channel on housing 42, with thesutures 120, 122 remaining above these longitudinal channels to contactcutting edge 54 a of knife 54 (FIGS. 25 and 26) to sever the sutures120, 122 as shown in FIG. 26. Note engagement members 123, 125 can floatinside the channel because they are no longer in tension. The sutures120, 122 can be further tightened and then trimmed by the surgeon to beflush with the patient's skin.

An alternate embodiment of the hole closure delivery instrument isillustrated in FIGS. 27-41. In this embodiment, the handle portionperforms the multiple steps of advancing the advancer (cheater) tube torotate the hinged casing at the end of advancer tube containing thecovering member 104 of the hole closure device 101 as well as advancesthe hole closure device 101 through the sheath for delivery to thevessel. After delivery, the instrument is retracted and the retainers110, 112 are advanced toward the covering member 104 in the same way asin the embodiment of FIGS. 1-26.

Turning first to FIGS. 27 and 30A, delivery instrument is designatedgenerally by reference numeral 212 and has a winged housing 214, aplunger guide housing 216 formed by housing halves 240 a, 240 b and ahandle portion or pusher (plunger) 260. Plunger 260 is slidably receivedwithin guide housing 216.

Winged housing 214 is connected to end cap 217, preferably by aninterference or snap fit as distal end 219 is dimensioned to receive endcap 217 thereover. End cap 217 has locking tabs 218 a, 218 b (FIG. 29)on opposing sides to engage sheath 200 in the same manner as lockingtabs 21 of end cap 20 of the embodiment of FIG. 1.

Winged housing 214 has a pair of wings 214 a, 214 b extending radiallytherefrom for grasping by the user to facilitate movement of the plunger260 and to aid in retraction of the delivery instrument 212 after thehole closure device 101 is delivered to the vessel lumen. Cap 217 has anopening 217 a through which side arm 201 of sheath 200 can extend as inopening 20 a of end cap 20. Side arm 201 provides for delivery of fluidsthrough the sheath 200.

Supported within a distal end of guide housing 216 is an advancer 220.Advancer is in the form of a tube 220 which forms a cheater tubeslidable within guide housing 216 and winged housing 214. Advancer tube220, like advancer tube 39 of the embodiment of FIG. 1, is in the formof a tube cut at the distal end to form a hinge 228 b. The cut portionforms a casing 228. Casing 228 is somewhat cylindrical shaped with abeveled end 228 a formed by the cut in the tube as shown in FIG. 31A.Casing 228 forms a support housing for the covering member 104 of holeclosure device 101. The casing 228 is initially mounted within thewinged housing 214 in a position substantially transverse to alongitudinal axis of the winged housing 214 as shown in FIG. 31A. Distalmovement of the advancer tube 220 pivots the casing 228 (in the samemanner as casing 28 of FIG. 8A) about hinge 228 b as it contacts curvedsurface 214 c within winged housing 214 to a more linear positionsubstantially aligned with the longitudinal axis of the winged housing214 in the same manner as casing 28 shown in FIG. 10. That is, casing228 is pivoted from the initial transverse position of FIGS. 31A and 33to the aligned position of FIGS. 34A and 35). This allows for pivotingmovement of the elongated covering member 104 to reposition it to a morealigned position for advancement through the sheath 200. Note also thatin the alignment position of casing 228, the beveled distal end 221 ofadvancer tube 220 abuts the beveled end 228 a of casing 228 (as incasing 28 of FIG. 10).

With reference to FIG. 30A, advancer tube 220 has offset wings 220 a,220 b. One of the wings, e.g. wing 220 a, can have indicia to indicatealignment of the casing 228. A clip 275 (see also FIG. 29) provides astop to prevent inadvertent movement of the advancer tube 220, e.g.during shipping. That is, distal edges 223 a, 223 b of wings 220 a, 220b abut the legs 275 a, 275 b, respectively, of clip 275, thus preventingdistal movement of advancer tube 220 unless the clip 275 is removed.Thus, clip 275 also provides a shipping lock. The upper edge 225 a (asviewed in the orientation of FIG. 34A) of edge 223 a and a lower edge225 b of edge 223 b abut internal wall 248 a and 248 b, respectively, ofguide housing 216, to prevent further distal movement of advancer 220 asdescribed in more detail below. That is, when advancer 220 is moveddistally to the position of FIG. 34A, walls 248 a, 248 b block furtherdistal movement. Note the internal walls 248 a, and 248 b are formed bythe two housing halves 240 a, 240 b.

A seal 258, with an opening 258 a for receiving outer tube 280, preventsthe ingress of fluids. The seal 258 is mounted in the distal portion ofguide housing 216 within an opening in cap 257 which is fixed to housing216 by a pair of transverse pins 256 extending into a pair of sideopenings 257 a of cap 257.

First and second rails 250, 252, extend between plunger 260 and wings220 a, 220 b. More specifically, upper rail 250 (as viewed in theorientation of FIGS. 30A and 31A-31C) extends within guide housing 216between the plunger 260 and wing 220 a of advancer tube 220. A lowerrail 252 (as viewed in the orientation of FIGS. 30A and 31-31C),positioned within guide housing 216 on a different plane than rail 250,extends between plunger 260 and wing 220 b of advancer tube 220. Asshown in FIG. 33, rail 250 has a distal finger 250 a, an intermediatefinger 250 b, and a proximal finger 250 c extending upwardly to engageinternal walls of the guide housing 216 discussed in detail below.Similarly, rail 252 has a distal finger 252 a, an intermediate finger252 b, and a proximal finger 252 c extending downwardly to engageinternal walls of the guide housing 216 also discussed in detail below.The distal edges 250 d, 252 d of distal fingers 250 a, 252 a abutinwardly extending walls 243 a, 243 d of guide housing 216 (FIG. 31A),and the proximal edges 250 e, 252 e, of proximal fingers 250 c, 252 c,abut inwardly extending walls 243 c, 243 f of guide housing 216 (FIG.31B) in the initial position.

The distal end of finger 250 a of rail 250 is received in slot 220 d ofwinged housing 220 a; the distal end of finger 252 b of rail 252 issimilarly received in a slot in winged housing 220 b (see FIGS. 33 and37). The proximal finger 250 c of rail 250 is received in slot 267 a inplunger housing 260; proximal finger 252 c of rail 252 is similarlyreceived in a slot on the opposing side of plunger housing 260. Rails250, 252 function to initially advance advancer tube 220 when plunger260 is advanced, and then are moved out of operative engagement withwings 220 a, 220 b so the plunger 260 advances while the advancer tube220 remains stationary as the outer tube 280 is advanced within advancertube 220.

With reference to FIG. 30B, plunger 260 includes housing halves 261 a,261 b. Contained within the housing halves 261 a, 261 b are firstchannel housing 264, second channel housing 266 and central housing 268.These channel housings are identical to housings 40, 42, and 44 of FIGS.1-26 to provide movement of the sutures 120, 122 of the hole closuredevice 101 and their respective engagement members to advance theretainers 110, 112 of the hole closure device 101 and therefore forbrevity are not further described herein or further labeled in thedrawings. Knife 274 is supported in the slots in the channel housings264, 266 and 268. Knife 274 is identical in structure and function toknife 54 of FIG. 2A. A shroud 276 is positioned above the knife 274 (asviewed in the orientation of FIG. 30B) to prevent inadvertent contact ofthe sutures 120, 122 with the knife 274 which can cause prematuresevering of the sutures 120, 122 of the hole closure device 101. (Ashroud can also be provided above knife 54 in the embodiment of FIG. 1).Grommets 270, 272, having engaging portions to form blocking or abutmentmembers for the engagement members 125, 123 on the end of the sutures120, 122 of the hole closure device 101, are identical to grommets 49,48, respectively, of FIG. 2A and therefore for brevity are not discussedin detail below since the description of the function of grommets 48,49, and the passage of engagement members 125, 123 are fully applicableto this embodiment of FIG. 30B. Consequently, when device 212 isretracted after delivery of the hole closure device 101 to the vessel,the sutures and engagement members pass through the channels in housing264, 266 and 268 in the same manner as in the embodiment of FIGS. 1-26to advance the retainers toward the covering member to secure the holeclosure device and to sever the sutures.

With reference to FIG. 30A, end cap 281 of inner tube 282 is securedwithin opening 260 a of plunger 260 by a snap or friction fit. Innertube 282 is received in the lumen of outer tube 280. A reinforcing tube284, preferably composed of stiffer material, is concentricallyinterposed between the inner tube 282 and outer tube 280. Outer tube 280is attached to the end cap 281 of plunger 260 so that distal movement ofplunger 260 advances the outer tube 280 through the lumen in advancertube 220 to contact spherical retainer 110 of the closure device 101 toadvance the closure device 101 through the sheath 200 and into thevessel. The inner tube 282 has a pair of lumens to receive respectivesutures 120, 122.

Proximal and distal sleeves 247 b, 247 a surround the housing halves 240a, 240 b of the guide housing 216 to secure them together.

In use, in the initial position of FIGS. 31 a-31 c (and FIG. 33),plunger 260 is in its proximalmost position and advancer tube 220 is inthe proximalmost position as edges 223 a, 223 b of wings 220 a, 220 b,respectively, abut clip 275. Thus, in this initial position, with thelocking clip 275 in place, distal movement of plunger 260 is blocked.Note in this position, casing 228 (and hole covering member 104contained therein) are in the transverse position. Rails 250, 252 whichextend between plunger 260 and wings 220 a, 220 b, are positioned suchthat edge 250 e of proximal finger 250 c of rail 250 is in contact withthe edge of proximal radially inwardly extending internal wall 243 c ofhousing 216 and edge 252 e of proximal finger 252 c of rail 252 is incontact with the edge of proximal radially inwardly extending wall 243 fof housing 216, best shown in FIG. 31B. Additionally, edge 250 d ofdistal finger 250 a is in contact with the edge of distal radiallyinwardly extending internal wall 243 a of housing 216 and edge 252 d ofdistal finger 252 a is in contact with the edge of distal radiallyinwardly extending wall 243 d of housing 216. Thus, the fingers 250 a,250 b, 250 c of rail 250 are spaced from the spaces between walls 243 a,243 b and 243 c, and the fingers 252 a, 252 b and 252 c of rail 252 arespaced from the spaces between walls 243 d, 243 e and 243 f.

To actuate the delivery instrument 212 to advance the plunger 260 tomove the advancer tube 220 distally in the first stage of operation,clip 275 is manually removed from the openings 251 a, 251 b of guidehousing 216 (FIG. 32) and plunger 260 is advanced distally. Such distaladvancement advances the advancer tube 220 due to the engagement ofrails 250, 252 with wings 220 a, 220 b of advancer tube 220. Advancementof the advancer tube 220 causes casing 228 to pivot from its transverseposition to the longitudinally aligned position of FIGS. 34A and 35 asthe casing 228 is forced against internal curved wall 214 c. The plunger260 is advanced so that aligned casing 228 is moved through wingedhousing 214 and into a proximal region of sheath 200. Note that thelongitudinal alignment of casing 228 pivots covering member 104 of holeclosure device 101 to a more aligned position for delivery through thesheath 200 to the vessel lumen. Note that roller pins 259 (FIGS. 34B and35) on opposing sides of plunger 260 ride within longitudinal track 253of housing 240 b and a similar longitudinal track in housing 240 a,thereby acting as low friction bearings within the tracks in housinghalves 240 a, 240 b for smoother motion of the plunger 260 within guidehousing 216. This advanced position of tube 220 and intermediateposition of plunger 260 are shown in FIGS. 34A-34C and 35.

Note that plunger 260 advances advancer tube 220 until the distal edges225 a, 225 b of wings 220 a, 220 b abut edges 248 a, 248 b of housing216 as shown in FIG. 34A. In this position, plunger 260 has advanced toan intermediate region of guide housing 216. As the advancer tube 220 isthus blocked against further distal movement by edges 248 a, 248 b,further distal movement of plunger 260 does not advance advancer tube220. Instead, as plunger 260 is advanced, distal edges 250 d and 252 dof rails 250, 252, respectively, and 250 g of rail 250 have moved pastthe distal edges of respective distal radially extending walls 243 a and243 d and proximal edges 250 e, 252 e of rails 250, 252 respectively,have moved past the distal edges of the respectively radially extendingproximal walls 243 c, 243 f. However, proximal edge 250 f of distalfinger 250 a and proximal edge 252 f of distal finger 252 remain engagedwith walls 243 a, 243 d. Further, proximal edges 250 g, 252 g ofintermediate fingers 250 b, 252 b, respectively, are engaged with distaledges of walls 243 b, 243 e (FIG. 34B). Upon further distal movement ofplunger 260, proximal, intermediate and distal fingers 250 a, 250 b and250 c of rail 250 extend into the respective spaces between walls 243 a,243 b and 243 c and the proximal, intermediate, and distal fingers 252a, 252 b and 252 c of rail 252 extend into the respective spaces betweenthe walls 243 d, 243 e and 243 f as shown in FIGS. 36A, 36B and 37 asedges 250 f, 252 f and 250 g, 252 g clear the respective walls. Whenthis occurs, rail 250 comes out of the slot 220 d in wings 220 a andrail 252 comes out of the slot in wing 220 b so the rails 250, 252 aredisengaged from wings 220 a, 220 b and thus the advancer 220 is nolonger in operative engagement with plunger 260. Note rails 250, 252ride within ramps in the wings 220, 220 b. That is, in this position ofrails 250, 252, advancement of plunger 260 no longer advances advancer220 and instead, advancement of plunger 260 moves the outer tube 280with respect to the advancer 220 which is now stationary.

Upon further distal advancement of plunger 260 to its distalmostposition as shown in FIGS. 39A-39C and 38, outer tube 280 moves withinstationary advancer tube 220 as the wings 220 a, 220 b are blocked bywalls 248 a, 248 b from further advancement, and the rails 250, 252 areno longer in operative engagement with the wings 220 a, 220 b. As outertube 280 is advanced through winged housing 214 and into the sheath 200,it continues to advance the hole closure device 101 through the sheath200 and into the vessel as it engages retainer 110. That is, full distaladvancement of plunger 260 advances the hole closure device 101 from thedistal end of the sheath 200. This position is shown in FIG. 35. In thisdistalmost position, pins 259 are locked by locking tabs 241 a, 241 b toprevent proximal movement thereof. That is, when plunger 260 hascompleted its stroke, pins 259 have bypassed locking tabs 241 a, 241 band are now blocked from proximal movement by these tabs 241 a, 241 b.

Once the plunger 260 is fully advanced and locked in its distalposition, i.e., blocked from proximal movement, the delivery instrument212 is retracted in the same manner as delivery instrument 100 of FIGS.1-26 to advance the retainers 110, 112 toward covering member 104 and toautomatically sever the sutures 120, 122 by knife 274 as the sutures120, 122 and engagements members slide within the channels in thehousings of FIG. 30B.

While the above description contains many specifics, those specificsshould not be construed as limitations on the scope of the disclosure,but merely as exemplifications of preferred embodiments thereof. Thoseskilled in the art will envision many other possible variations that arewithin the scope and spirit of the disclosure as defined by the claimsappended hereto.

1. A surgical delivery instrument for delivering a vascular hole closure device having a hole covering member, the delivery instrument comprising a housing, a plunger and an advancer movable within the housing, the advancer having a first portion and a distal portion hingedly connected to the first portion and forming a casing for supporting the hole covering member, wherein distal movement of the advancer pivots the casing from an angled position to a more linear position to change the orientation of the covering member from an angled position to a more aligned position, the plunger advanceable to advance the covering member into the vessel.
 2. The surgical delivery instrument of claim 1, wherein the hole closure device includes first and second flexible members, the first flexible member having a first engagement member and the second flexible member having a second engagement member, wherein the plunger has first and second longitudinally extending openings and first and second engaging portions, the first engaging portion limiting movement of the first engagement member and the second engaging portion limiting movement of the second engagement member, wherein the first engagement member is held by the first engaging portion until a predetermined force is applied to the first engagement member during placement of the closure device at a target site and the second engagement member is held by the second engaging portion until a predetermined force is applied to the second engagement member during placement of the closure device at the target site.
 3. The surgical delivery instrument of claim 2, wherein the first engaging portion comprises a first opening in a first grommet aligned with the first longitudinally extending opening and the second engaging portion comprises a second opening in a second grommet aligned with the second longitudinally extending opening.
 4. The surgical delivery instrument of claim 1, wherein the housing includes an angled inner surface engagable by the casing to pivot the casing to the more linear position.
 5. The surgical delivery instrument of claim 1, wherein the plunger includes a tube and a handle portion positioned proximally of the tube, and movement of the handle portion distally advances the tube within a lumen of the advancer.
 6. The surgical delivery instrument of claim 1, further comprising a distal stop to limit distal movement of the advancer.
 7. The surgical delivery instrument of claim 1, further comprising a first actuator for moving the advancer distally, the first actuator movable independently of the plunger.
 8. The surgical delivery instrument of claim 1, wherein initial advancement of the plunger moves the advancer distally and subsequent advancement of the plunger advances the covering member into the vessel.
 9. A surgical delivery instrument for delivering into a vessel a vascular hole closure device having a hole covering member, the delivery instrument comprising a housing, an advancer movable within the housing, and a plunger, the advancer movable to change the position of the covering member within the housing and the plunger subsequently movable to advance the covering member from the housing into the vessel.
 10. The surgical delivery instrument of claim 9, wherein movement of the plunger moves the advancer to change the position of the covering member.
 11. The surgical delivery instrument of claim 9, further comprising a first actuator for moving the advancer, the first actuator movable independently of the plunger.
 12. The surgical delivery instrument of claim 11, further comprising a stop to limit movement of the advancer, wherein the plunger is movable within the advancer when the advancer comes into contact with the stop.
 13. The surgical delivery instrument of claim 1, further comprising first and second rails operatively connecting the advancer and the plunger.
 14. The surgical delivery instrument of claim 12, wherein the first and second rails are operatively dissociated from the plunger when the advancer is moved to a distal position into contact with the stop.
 15. A surgical delivery instrument for delivering a vascular hole closure device having a first flexible member having a first engagement member extending therefrom and a second flexible member having a second engagement member extending therefrom, the delivery instrument comprising a housing having first and second longitudinally extending lumens and first and second members, the first member having a first opening aligned with the first lumen, the second member having a second opening aligned with the second lumen, the first engagement member passing through the first opening when a predetermined proximal force is applied and the second engagement member passing through the second opening when a predetermined proximal force is applied, wherein the first engagement member is held by the first member until the predetermined proximal force is applied to the first engagement member during placement of the closure device at a target site.
 16. The delivery instrument of claim 15, wherein the second engagement member is held by the second member until the predetermined proximal force is applied to the second engagement member during placement of the closure device at the target site.
 17. The delivery instrument of claim 16, wherein the first flexible member is a suture and the second flexible member is a suture, and the delivery instrument further comprises a cutting member positioned within the housing for automatically severing the sutures.
 18. The delivery instrument of claim 15, wherein the first member has a third opening and the second member has a fourth opening, wherein the first engagement member is passable through the first opening when a first force is applied and subsequently passable through the third opening when a subsequent force is applied.
 19. The delivery instrument of claim 18, wherein the second engagement member is passable through the second opening when a second force is applied and subsequently passable through the fourth opening when a subsequent force is applied.
 20. The delivery instrument of claim 15, wherein the vascular hole closure device has a covering member at a distal end for positioning internal of a vessel and a first and a second retainer for positioning external of the vessel, the first flexible member extending between the covering member and the first retainer and the first engagement member positioned at a proximal portion of the first flexible member, and the second flexible member extending between the covering member and the second retainer and the second engagement member positioned at a proximal portion of the second flexible member, wherein proximal movement of the delivery instrument advances the first retainer and the second retainer toward the covering member. 